Thursday, January 24, 2008

Say It Ain’t So, Donald
Steroids in Baseball Blamed on Dietary Supplements
In the latest twist in the baseball players’ steroid use scandal, congressional hearings following the release of the Mitchell Report have generated a new controversy: MLB players union chief Donald Fehr has apparently tried to shift part of the blame to poor regulation of dietary supplements, suggesting that players may have accidentally ingested banned drugs due to poor manufacturing practices in an industry deregulated by the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Let me be blunt: What a bunch of bull! First of all, it is ridiculous to try to point the blame at dietary supplements as the cause of professional athletes’ steroid use, implying that the players were doped against their will. I can’t believe for a minute that world-class athletes don’t have their expert trainers carefully scrutinize products before using them, and then only as part of a complete nutritional program. Either the players or their trainers know, or should know, what they’re taking. Does anyone really believe that players are impulsively buying crappy supplements in gas stations? Please!
In fact, DSHEA does not allow steroids to be used in dietary supplements. DSHEA actually makes it illegal to sell dietary supplements containing any undisclosed ingredients, making them by definition “adulterated” and subject to strict FDA action. DSHEA also requires that all health claims be submitted to the FDA, and prohibits any new dietary ingredients without first registering safety information with the agency. The Bioterrorism Act also requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA. Please check the FDA website and see it all for yourself. (3)
It is plainly illegal to sell any restricted substances - drugs - without OTC status or a physician's prescription, and all drugs require specific labeling. It is also illegal to sell anabolic steroid precursors like androstene in this country because of another law that was strongly supported by the dietary supplement manufacturers. A New York Daily News article (2) uncritically echoed the unbelievable argument that supplements are now unregulated because of DSHEA and reprinted an outrageous quote by someone who should know better, alleging that “DSHEA was created in order to give the supplement manufacturers a huge shield so they could distribute steroids”, despite the obvious restrictions and regulations that the law imposes. Mr. Fehr’s questionable allegations were featured on AOL, CNN, ESPN, and news feeds that went around the world; sometimes with sympathetic journalists adding similar sentiments and supporting quotes. But we can see the facts for ourselves on the FDA’s own website, proving it ain’t so. (1)
Dietary supplement manufacturers also supported FDA’s dramatically increased regulation of supplement manufacturing (cGMPs, or current Good Manufacturing Practices); which was authorized by DSHEA, by the way. The industry even supported mandatory reporting of serious adverse events linked (possibly related) to their products, which is now in effect.
It is clear by the record that the dietary supplement industry has consistently supported increased regulation of its own operations and products as a good faith effort to protect its customers, an estimated 2/3 of American adults, even though DSHEA has obviously given the FDA additional regulatory authority over a number of areas. The industry has even lobbied Congress for additional FDA funding to improve the agency’s enforcement of dietary supplement regulations, an incredible effort by an industry to increase government regulation of that same industry. This support should come as no surprise, since the industry is focused on the scientific use of nutrition as a means to offer healthy alternatives for people trying to avoid the use of drugs in the first place. Drugs are dangerous controlled substances, by definition, and nutrients are regulated as a special food category.
In this case, Rep. Waxman seemed quite willing to believe the hype, but his history evidences his unwavering belief that the dietary supplement industry is under-regulated, even as more and more layers of regulation are added. Could it be that Mr. Fehr simply, and successfully, gambled that he could distract his inquisitor by providing another target that might be welcomed by such a prominent industry critic?
In my opinion, this whole baseball doping controversy really has nothing to do with sloppy supplement manufacturing or poor regulation of the dietary supplement industry, which I consider slanderously false accusations, and everything to do with deliberate illegal drug dealing and steroid use by those who are now desperately trying to find a scapegoat.
1. http://www.cfsan.fda.gov/~dms/ds-ind.html
2. http://www.nydailynews.com/sports/baseball/2008/01/16/2008-01-16_donald_fehr_admits_mlb_players_union_res.html?page=0
3. http://www.cfsan.fda.gov/~dms/supplmnt.html

Monday, January 14, 2008

CNN’s erroneous report on dietary supplement regulation was corrected after my complaint and correction
By Neil E. Levin, CCN, DANLA
www.honestnutrition.com
A recent CNN text report and the accompanying video posted on its webpage asserted that dietary supplements are “unregulated” and that label and ad claims are made without any government supervision. 1 The video was shown on the CNN television network. Of course, one need only go to the FDA's own web site to find out that this is false. Even the claim that dietary supplements are "unregulated" compared to other food categories is preposterous.
The FDA says that (I have bolded certain words in these quotes to emphasize that these are mandatory rules, or regulation): "FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter)."
The agency explains the scope of those regulations: "FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting [Neil's note: this has been superceded by mandatory adverse event reporting passed into law December 2006.] , and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising...Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA."
Regarding the regulation of claims and labels, the agency says: "Claims that can be used on food and dietary supplement labels fall into three categories: health claims, nutrient content claims, and structure/function claims. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, or, in the case of advertising, with the Federal Trade Commission...Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA no later than 30 days after marketing the dietary supplement that includes the text of the structure/function claim."
"The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to: http://www .ftc.gov/bcp/menu-health.htm. Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service."
Regarding new ingredients, the agency says, "The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply." This rule does not apply to other food categories.
Additionally, serious adverse event reporting (SAERs) is no longer voluntary. Manufacturers are required to report SAERs to the FDA within 15 business days of receipt, another distinction between dietary supplement regulation and rules for other regulated food categories. And the FDA, as authorized by DSHEA, is phasing in mandatory cGMPs (current Good Manufacturing Practices) for all dietary supplement manufacturers, focusing on assuring safety and proper identification of ingredients by setting strict rules for manufacturing procedures. This is another important regulatory distinction between dietary supplements and other food categories.
POSTSCRIPT:
I sent a short version of this correction to CNN on Monday, 1/14/08, and posted a long version on my blog. To their credit, CNN has now (1/17/08) posted a link to my blog entry (1) that had complained about the accuracy of its original report, has revised its text version on the CNN webpage to remove the errors that I pointed out to them and insert accurate quotes from the FDA website, and has pulled the video of that original report from the CNN webpage. (2)
I acknowledge CNN’s corrections as responsible and applaud its efforts to quickly correct these errors when informed of them.
My hope is that CNN will now be more vigilant in recognizing and challenging the common misperception that “dietary supplements are unregulated”, since even a quick fact check reveals that this is quite untrue. Even when those making these false claims are authorities, “experts” or health professionals, it would be helpful if journalists learn that such blanket condemnations are ‘red flags’ indicating that sources may be spouting personal opinions that may be inaccurate, biased, inflammatory, or even potentially libelous; and hopefully triggering a healthy skepticism instead of a mere echo.
Links:
1. http://honestnutrition.blogspot.com/2008/01/cnn-false-report-on-dietary-supplement.html
2. http://www.cnn.com/2008/HEALTH/diet.fitness/01/11/hfh.supplements/index.html

Monday, January 07, 2008

Selective facts produce poor journalism (or science).
For example, the Women's Health Study had a 7% reduction in major cardiovascular events with vitamin E, a number that was not significant. But there was a significant 24% reduction in cardiovascular death in the vitamin E group. Would you characterize that as a failure for vitamin E? The media did.
Yet, the authors of the study admitted that, "This was largely attributable to fewer sudden deaths in the vitamin E group (38 vs 51 among women assigned to placebo) and fewer deaths from other cardiovascular disease (ie, deaths due to cardiovascular diseases other than ischemic heart disease and cerebrovascular disease, 20 vs 34, respectively)."
The Williams College ginkgo study in JAMA allowed participants to miss up to 6 daily doses over a 2-week period (nearly 50%!) before they were eliminated for non-compliance. It also tested only one brand of ginkgo (Ginkoba) on healthy volunteers for only six weeks, with results (by convention) not applicable to other brands. This was an obvious attempt to see whether a quick, drug-like effect could be obtained from a short course of supplementation. Longer term studies are more authoritative, especially if compliance is better.
The CoQ10 statement is laughably wrong: "Coenzyme Q10 has not been carefully tested to see if it is safe and effective. Because coenzyme Q10 is sold as a dietary supplement rather than a drug, it is not regulated by the US Food and Drug Administration."
This is a complaint that the FDA does not test individual dietary supplement products for potency or approve individual label claims. The agency does have the longstanding right to veto dietary supplement label claims and to remove any mislabeled or adulterated product from the national market. This contrasts with the FDA's explicit approval of drugs and drug claims, though the agency doesn't test individual pharmaceuticals for potency or safety, either. Of course, the FDA would take issue with their supposed inability to regulate dietary supplements. They even claim the opposite on their web page. Note the first 4 words:
"FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading. FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising."
regarding the CNN report:
http://www.cnn.com/2007/HEALTH/04/09/chasing.supplements/index.html

Thursday, January 03, 2008

CR Wrong on Dietary Supplements
By Neil E. Levin, CCN, DANLA
Consumer Reports published an article on dietary supplements in January 2008, titled, “Risky Pills – Supplements to avoid”. Unfortunately, CR may have failed to live up to its reputation as an impartial arbiter of quality, apparently relying on its medical and research consultants’ opinions instead of actually testing products. How informed and impartial are these sources on this particular topic?
Of course, there is no excuse for companies that blatantly break the law by illegally and knowingly adulterating dietary supplements with drugs or banned substances. The dietary supplement industry asks the FDA and FTC to throw the book at those bad apples pretending to be legitimate businesses.
In fact, manufacturers overwhelmingly supported recent legislation – now the law of the land – to put teeth into FDA enforcement powers by banning steroid precursors, regulating manufacturing requirements (cGMPs, current good manufacturing practices) and instituting mandatory reporting of serious adverse events.
The supposed burden on the FDA “to prove that a supplement creates “a significant or unreasonable risk” before it can demand its removal” is actually a very low bar, now that the US Supreme Court has allowed a ban on the herb Ephedra without requiring proof that the agency had followed the law, or even its own regulations, in the process.
In the CR report, several dietary supplements are singled out for criticism, but with some startling omissions of fact. Androstenedione products (anabolic steroid precursors) have already been outlawed, with the explicit support of the dietary supplement industry. Only rogue manufacturers carry them because they are clearly illegal. Chaparral is mentioned as a present danger, but reputable manufacturers voluntarily withdrew the herb after an FDA warning – back in 1992. Organ and glandular tissues are singled out for risk of Mad Cow disease, but only certain ones are vulnerable and these have largely disappeared from the marketplace. Most glandular tissues are carefully obtained from range-fed animals in New Zealand or Argentina, from areas with no reported cases of this disease.
The alkaloid synephrine from Bitter Orange (Citrus aurantium) often gets accused of causing “high blood pressure, heart arrhythmias, heart attack, stroke”. Yet the FDA Medwatch program’s web page does not list a single substantiated complaint of the herb causing these symptoms. Most Bitter Orange is used in formulations along with caffeine and other legal stimulants. In fact, there is evidence that Bitter Orange is not responsible for some of these products’ side effects: “Ephedra-free weight loss supplements have significant cardiovascular stimulant actions, similar to ephedra. These effects are not likely caused by C. aurantium alone, because an eightfold higher dose of synephrine … had no effect on blood pressure, but may be attributable to caffeine and other stimulants in the multi-component formulation.” (The American Journal of Medicine (2005) 118, 998-1003).
In 2004, attorney Marc Ullman requested FDA records on Bitter Orange adverse events from the FDA under the Freedom of Information Act. Scrutinizing these files, he found that many so-called adverse events supposedly related to Bitter Orange were actually for unrelated products, combination formulas, pre-existing conditions etc; reporting that, “In its response to the April 14 FOIA, FDA disclosed it had conducted no research whatsoever concerning either the safety or efficacy of Citrus aurantium.” (Natural Products Insider) The American Herbal Products Association also reviewed every adverse event report on Bitter Orange disclosed under another FOIA request and, after eliminating products also containing ephedra and/or caffeine, found only one minor adverse event (weakness, leg swelling) remaining in the FDA archives, which involved a woman also being medicated for osteoarthritis, hypertension, and diabetes. (HerbalGram. 2006;69:52-55)
Another study reported that, looking at formulations including Bitter Orange and caffeine with other herbs, “Laboratory testing (including vital signs, serum chemistries, CBC with differential, urinalysis, and electrocardiography) revealed no significant changes.” (Curr. Ther. Res., 60, 145 - 153.) And in another report, “Bitter orange dried-fruit extract did not significantly alter the [heart rate] or blood pressure after a single dose was administered.” (Pharmacotherapy, Dec. 2005) Yet another study reported that bitter orange had no significant effects on any of the cardiovascular variables measured. (Journal of Clinical Pharmacology, 2001;41:1059-63) Another small study reported small increases in these measures, but the point is that strong cautions are premature, at best. One expert has stated that synephrine works differently if synthesized or injected, rather than orally taking the natural herbal extract. (Experimental Biology and Medicine (vol. 229) and Washington Post 9/7/05). There is still reasonable doubt that Bitter Orange supplements have caused any serious adverse events.
The herb kava is also the subject of a caution. I personally use this herb, and have looked at the few, unverified reports relating to liver problems and concluded that they are anecdotal and probably unrelated to use of the herb. Some toxicology experts note that the vast majority of such reports are unverified and that “kava extracts continue to demonstrate a far better risk-to-benefit ratio [than medical options].” (Toxicology Letters, Volume 150, Issue 1, 15 April 2004) My routine liver function tests remain optimal.
I was surprised that CR touts the “USP Verified” mark, a certification that is not even as stringent and broad-based as the new federal cGMPs, which are mandatory. This explicit endorsement of a commercial testing program that does not yet meet the new national standard seems misplaced, and is also unfair to imply that GMP-certified manufacturers audited by competing certifying agencies have lesser quality controls.
I believe that CR has missed the mark in portraying dietary supplements as dangerous and unregulated by using inconclusive, outdated and unrepresentative data. Why doesn’t the magazine to raise its coverage of these issues to the same high standard as its other reporting? Scaring consumers into using more dangerous medical treatments by such methods may sell magazines and gain media exposure, but at the cost of CR’s credibility, consumers’ wallets and real lives lost. Reactions to properly prescribed pharmaceutical drugs reportedly cause over 100,000 deaths per year and may be the fourth leading cause of death in the US; even ignoring medical errors and overdoses. (JAMA, Apr 1998; 279: 1200 - 1205.) Positioning herbs and other dietary supplements as dangerous, when they are rarely life-threatening, is irresponsible and completely disproportional to their relative safety.

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About Me

Neil E. Levin, CCN, DANLA is a nationally board-certified clinical nutritionist with a Diplomate in Advanced Nutritional Laboratory Assessment. He is a professional member of the International & American Associations of Clinical Nutritionists.
Neil is a nutrition educator and a dietary supplement formulator.
Neil is a member of the Scientific Council of the national Clinical Nutrition Certification Board and is on the board of directors of the Mid-American Health Organization (MAHO), the Midwest regional affiliate of the National Products Association (NPA). In July, 2008, Neil was named an NPA Industry Champion, "an award given to people who have made notable individual contributions to industry above and beyond what is expected to achieve commercial success".
Neil is the immediate past president and Program Chair of the American Nutrition Association (americannutritionassociation.org).
Neil is frequently published or quoted in magazines, newspapers, and scientific journals and has been on numerous radio and television news programs. Follow me on Twitter: neilelevin